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510(k) Data Aggregation

    K Number
    K143692
    Device Name
    GranOSTM - beta tricalcium phosphate synthetic bone granules
    Manufacturer
    Date Cleared
    2015-08-21

    (240 days)

    Product Code
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    TCM ASSOCIATES LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    GranOS™ devices are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. GranOS™ is indicated to be gently placed into bony voids or gaps of the skeletal system (ie the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
    Device Description
    GranOS™ is a porous, resorbable osteoconductive scaffold constructed of highly pure beta tricalcium phosphate granules for use in the repair of bony defects.
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